Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT01073566
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01073566
Study Brief: Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Finesse Bolus Patch None None 1 38 8 38 View
Usual Injection Device Pen/Syringe None None 1 38 9 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Bronchitis None Respiratory, thoracic and mediastinal disorders None View
Acute Pancreatitis None Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tooth ache None Gastrointestinal disorders None View
Tooth disorder None Gastrointestinal disorders None View
Medical device site reaction None General disorders None View
Acute pyelonephritis None Infections and infestations None View
Flu None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Upper respiratory infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Knee pain None Musculoskeletal and connective tissue disorders None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Postnasal drip None Respiratory, thoracic and mediastinal disorders None View
Respiratory disorder None Respiratory, thoracic and mediastinal disorders None View
Respiratory tract congestion None Respiratory, thoracic and mediastinal disorders None View
Gastroenteritis eosinophilic None Gastrointestinal disorders None View